- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073799
Storage Symptom After Laser Prostatectomy
February 25, 2014 updated by: Seoul National University Hospital
Change in Storage Symptoms Following Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP).
However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP.
Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively.
The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
486
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Recruiting
- Department of Urology, Seoul National University Hospital
-
Contact:
- Min Chul Cho, doctor of philosophy
- Phone Number: 82-10-6271-4023
- Email: cmc1206@empal.com
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Principal Investigator:
- Jae-Seung Paick, doctor of philosophy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate and in whom 12-months follow-up data were available
Description
Inclusion Criteria:
- Clinical diagnosis of prostatic hyperplasia
- underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
- 12-months follow-up data were available
Exclusion Criteria:
- previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Photoselective vaporization of the prostate
Patients who underwent photoselective vaporization of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available
|
|
|
Holmium laser enucleation of the prostate
Patients who underwent holmium laser enucleation of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the subtotal storage symptom score of the International Prostate Symptom Score (IPSS)
Time Frame: 12 months after surgery
|
a reduction by ≥ 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline
|
12 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
February 23, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimate)
February 27, 2014
Study Record Updates
Last Update Posted (Estimate)
February 27, 2014
Last Update Submitted That Met QC Criteria
February 25, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LaserP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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